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Reuters Health Information (2013-01-31): Experimental liver cancer therapy fails in late-stage trial

Drug & Device Development

Experimental liver cancer therapy fails in late-stage trial

Last Updated: 2013-01-31 15:20:10 -0400 (Reuters Health)

(Reuters) - A late-stage study an experimental liver cancer treatment ThermoDox from Celsion Corp failed to meet the main goal of increasing patients' survival without worsening their cancer, sending shares of the company down more than 80%.

"I don't believe the data will support (marketing) registration in any of the major markets," Celsion Chief Executive Michael Tardugno said on a conference call.

ThermoDox utilizes a liposome as a vehicle to transport doxorubicin directly to the tumor. Localized heat releases doxorubicin, depositing it in and around the tumor, maximizing the effect of the medication.

The trial, named HEAT, consisted of 701 liver cancer patients across 11 countries and was designed to show a 33% improvement in progression-free survival.

Patients on the control arm performed about 20% better than expected whereas those on ThermoDox performed worse than anticipated, Roth Capital Partners analyst Joseph Pantginis said, quoting the company.

"We are disappointed by the failure of the HEAT study and we highlight the increased risk around the company's pipeline which is driven by ThermoDox," he said.

Celsion said it was conducting additional analyses of data from the trial to assess the future value of ThermoDox.

ThermoDox is also being tested in mid-stage studies as a drug-delivery method for breast and colorectal cancers.

Celsion CEO Tardugno said the company will continue enrolling patients in the mid-stage breast cancer study.

He also said the company will review its colorectal cancer trial in the context of the HEAT results and then decide on whether to continue with the study.

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